Omega & Delta Co., Inc.

Warning LetterOpen

Ruben De Quesada General Manager Omega & Delta Co., Inc. Carr. 887 Km 0 Hm 8 Julio N. Matos Ind. Park Bldg #10 Carolina 00985 Puerto RicoFEI 2650091Issued Nov 2, 2022Division of Pharmaceutical Quality Operations II

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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 2650091.

Violations4

Issue DateNov 2, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Omega & Delta Co., Inc.
Location: Ruben De Quesada General Manager Omega & Delta Co., Inc. Carr. 887 Km 0 Hm 8 Julio N. Matos Ind. Park Bldg #10 Carolina 00985 Puerto Rico
FEI Number: 2650091
Country: United States
Issue Date: November 02, 2022
Issuing Office: Division of Pharmaceutical Quality Operations II
Product Type: Drugs
Status: Open

Summary

Omega & Delta Co., Inc. was cited for manufacturing adulterated hand sanitizer products under insanitary conditions, with the FDA observing facility disrepair, poor cleaning, insects, cobwebs, and unexplained spills in manufacturing and raw material storage areas during an April-May 2022 inspection. The company failed to maintain adequate controls to prevent product contamination and violated Current Good Manufacturing Practice (CGMP) regulations, including failures by the quality control unit to meet its responsibilities. This represented a repeat compliance issue, as similar facility conditions had been observed during a previous FDA inspection in 2017.

Omega & Delta Co., Inc. FDA Warning Letter, November 2, 2022