Mr. Zachary Julius
Chief Executive Officer
Professional Disposables International, Inc.
2 Nice-Pak Park
Orangeburg , NY 10962-1317
United StatesFEI 2411192Issued Jan 7, 2022Division of Pharmaceutical Quality Operations I
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 2411192.
Violations4
Issue DateJan 7, 2022
Product TypeDrugs
StatusClosed
Closeout LetterDec 12, 2024
Letter Details
Firm
Professional Disposables International, Inc.
Location
Mr. Zachary Julius
Chief Executive Officer
Professional Disposables International, Inc.
2 Nice-Pak Park
Orangeburg , NY 10962-1317
United States
FEI Number
2411192
Country
United States
Issue Date
January 07, 2022
Issuing Office
Division of Pharmaceutical Quality Operations I
Product Type
Drugs
Status
Closed
Closeout Letter
December 12, 2024
Summary
Professional Disposables International, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of drug products at its Orangeburg, New York facility during a 2021 inspection. The company failed to thoroughly investigate out-of-specification (OOS) test results and unexplained discrepancies in batches or components, and failed to submit required NDA Field Alert reports to the FDA within the mandated three-working-day timeframe for bacteriological contamination or significant changes in distributed products. These deficiencies rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.
Professional Disposables International, Inc. FDA Warning Letter, January 7, 2022
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