Warning Letter: Database validation (ucm162745)

Failure to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of automatic, mechanical, or electronic equipment, including computers, used in the manufacture, processing, packing and holding of a drug product. [21 CFR 211.68]

The Enterprise Resource Planning System known as the firm’s Systems Applications and Products (SAP) computer database allows rejected batches of drug product to be in Unrestricted Status (to be released for distribution).

During the inspection, you provided our FDA investigators a spreadsheet that you stated contained data for calibration of [(b)(4)], however, you were not able to provide the raw calibration data. In addition, the calibration data for the [(b)(4)] that you provided in your December response in Attachment #9 do not correspond to the [(b)(4)] observed by our FDA investigators.

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Warning Letter: No validation of calculations (ucm162874)

Failure to maintain a written record and appropriate of computer or other automated processes used to perform calculations in connection with laboratory analysis [21 CFR § 211.68(b)]. Refer to FDA 483, Observation 12. For example, the accuracy of calculations performed by the [redacted] Spectrophotometer has not been verified.

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Warning Letter: Failure to establish procedures (ucm165301)

Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.

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Warning Letter: Failure to establish procedures (s7186c)

Failure to establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, the [redacted] used in the manufacturing of [redacted] products was changed from [redacted] to [redacted]. However, your validation records indicate [redacted] was used as the [redacted]. There are no records of design validation using [redacted] as the [redacted] furthermore, verification activities related to using [redacted] are not complete.

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Warning Letter: Failure to provide documentation for validation (ucm181430)

Purchase software specific to contact lens firms, which has quality system modules. You stated that you had purchased the software and planned to have it installed by January 2009, with implementation and validation within 5 to 6 months. However, you did not provide any documentation regarding the software system, the validation plan, or your firm’s plan to train personnel on the use of the system.

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Warning Letter: Failure to validate computer system (s7045c)

Failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR § 211.100(a)]. For example, your firm’s automated packaging line processes and their respective software systems have not been validated .

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Warning Letter: Lack of validation testing (s6906c)

Your validation of your device design is incomplete in that the firm has not established a protocol for conducting validation testing and did not validate the software to ensure that devices conform to the defined user needs and intended uses, as required by 21 CFR §820.30(g). Specifically, you have made 1,900 revisions to the software in three years without conducting validation testing .

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Warning Letter: Failure to maintain procedures, documentation (s6881c)

Failure to establish and maintain adequate procedures for the identification, documentation, validation or where appropriate verification, review and approval of design changes before their implementation, as required by 21 CFR 820.30(i).

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Warning Letter: Lack of controls and audit trails (ucm1048180)

The [redacted] data acquisition system for the [redacted] UV/Visible spectrophotometers allows your analysts to modify, overwrite, and delete original raw data files. The spectrophotometers are used for dissolution testing of finished product, stability samples, and process and method validation studies. All laboratory personnel were given roles as [redacted] Managers, which allowed them to modify, delete, and overwrite results files. This system also does not include an audit trail or any history of revisions that would record any modification or deletion of raw data or files. Your laboratory computer system lacks necessary controls to ensure that data is protected from tampering, and it also lacks audit trail capabilities to detect data that could be potentially compromised.”

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Warning Letter: Failure to Comply (s6876c)

• Failure to adequately validate manufacturing processes with a high degree of assurance, and approve and document the results of the validation activities, to ensure that product specifications can be consistently met, as required by 21 C.F.R. § 820.75(a). Specifically, your firm has not validated the milling process and documented the validation results to ensure that the brass rounds are correctly milled to patients’ programmed [redacted] files [redacted] codes).
• Failure to revalidate manufacturing processes in response to changes or process deviations, and document the results of the revalidation activities to ensure that product specifications can be consistently met, as required by 21 C.F.R. § 820.75(c). Specifically, your firm has not documented the results of the revalidation of the milling process after your firm repaired a loosened bushing on the tooling plate and [redacted] without established procedures in place for implementing these changes.
• Failure to establish and maintain procedures for verifying or validating, approving, and documenting changes to a specification, method, process, or procedure, before implementation, as required by 21 C.F.R. § 820.70(b). Specifically, your firm has not established written procedures describing how changes to your milling process are to be verified or validated, approved, and documented.

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