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# API Deviations at Specialty Process Labs
- URL: https://www.fdaweb.com/api-deviations-at-specialty-process-labs/
- Published: 2022-05-17T12:00:00.000Z
- Updated: 2026-09-14T17:44:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151826

An 11/8-11/10/21 FDA inspection at Specialty Process Labs, a Phoenix, AZ, drug manufacturing facility, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 5/3 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/specialty-process-labs-llc-624281-05032022?ref=fdaweb.com) lists specific deviations as: 

- failing to demonstrate that the firm’s manufacturing process can reproducibly manufacture an intermediate and API meeting its predetermined quality attributes;
- failing to ensure that, for each batch of intermediates and API, appropriate laboratory tests are conducted to determine conformance to specifications;
- failing to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failing to have adequate controls to prevent omission of data;
- failing to ensure that all test procedures are scientifically sound and appropriate to ensure that intermediate and API conform to established standards of quality; and
- failure of the quality unit to exercise its responsibility to ensure that API and intermediates manufactured at the firm’s facility comply with CGMP.

FDA says the firm’s responses to the inspection observations were inadequate. FDA strongly recommends that the firm engage a qualified consultant to assist it in meeting CGMP requirements.

The letter notes that similar CGMP deficiencies were observed at another facility in the company’s network. “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate,” it says. “Your executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.”

Specialty Process was told to correct deviations promptly and to respond with a list of specific actions it has taken to correct the deviations and prevent their recurrence, with a schedule for completing the corrections.