# FDA 483 - Metro Drugs 3rd Avenue Corp - April 05, 2019

Source: https://www.keypedia.com/records/483/metro-drugs-3rd-avenue-corp/a79cb927-6c34-4902-bdf8-ee626c051489

> FDA 483 for Metro Drugs 3rd Avenue Corp on April 05, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Metro Drugs 3rd Avenue Corp
- Inspection Date: 2019-04-05
- Product Type: Drugs
- Office Name: New York District Office
- Summary: From March 14, 2019, to April 5, 2019, the FDA inspected Metro Drugs 3rd Avenue Corp, a producer of sterile and non-sterile drug products located at 931 Lexington Ave, New York, NY 10065-5771. The inspection, documented in FEI number 3011795133, identified five observations.

Observation 1 noted the use of non-sterile disinfecting agents and wipes in the ISO 5 aseptic processing area. An aseptic operator was observed using non-sterile wipes to disinfect an ISO 5 laminar flow hood and as a placemat for sterile items during aseptic filling.

Observation 2 detailed the release of drug products with out-of-specification potency results. Examples included Liothyronine Sodium (T3) capsules with potencies ranging from 75.0% to 116%, Estriol/DHEA/Testosterone/Pregnenolone with DHEA at 81.3%, Estriol at 77.2%, and Testosterone at 84.5%, Methylcobalamin injectable at 53.3%, and Tri-Mix Quad and Atropine 0.1% Stock Solution with Atropine Sulfate Monohydrate potencies of 134.51% and 107.38% respectively. No product impact assessment was conducted for

## Related Officers

- [Investigator](https://www.keypedia.com/people/rachael-a-moliver/6130c1d8-9867-4da5-b113-1bbaf0ae9c79)

Company: https://www.keypedia.com/companies/metro-drugs-3rd-avenue-corp/947303b3-19ed-41dd-8ef9-8e856e0e3cf5

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d