Specialty Process Labs LLC — FDA Warning Letter Findings

Failure of your quality unit to exercise its responsibility to ensure the API and intermediates manufactured at your facility are in compliance with CGMP. Your firm’s quality unit (QU) failed to perform routine QU functions to ensure drug manufacturing operations were adequate. For example, your QU failed to: Establish and maintain adequate evaluation procedures for third-party laboratories that are utilized for finished drug testing, such as fat analysis, inorganic iodides…

Failure to ensure that, for each batch of intermediates and API, appropriate laboratory tests are conducted to determine conformance to specifications. You failed to perform laboratory testing to ensure that the thyroid, USP API lots held for extended periods of time met all quality attributes prior to blending into your final API blend. For example, lot (b)(4) , tested February 5, 2019, was blended, without retest, into finished thyroid, USP API, lot B20361-FS on February…

Failure to demonstrate that your manufacturing process can reproducibly manufacture an intermediate and API meeting its predetermined quality attributes. You failed to adequately validate your thyroid, USP API manufacturing processes. Specifically, there were several processing steps prior to the final blend, such as (b)(4) , and (b)(4) , that you did not include in your process validation. Your quality unit personnel stated that you planned to validate these processes in…

Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your intermediate and API conform to established standards of quality. The microbiological test methods used for determining the microbial attributes of your thyroid, USP API prior to release were deficient in the following: Growth promotion studies were not documented or conducted for either purchased or inhouse media. Method suitability and validation was not established or…

Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data. During the inspection, our investigator observed that many of your computerized systems lacked sufficient controls to ensure the integrity of the data being generated. For example: Our investigator found “System/Administrator” as the only user role for your (b)(4) software. There were no…