# FDA 483 - MasterPharm LLC - June 15, 2020

Source: https://www.keypedia.com/records/483/masterpharm-llc/c0057302-3430-4733-9681-57641dc63756

> FDA 483 for MasterPharm LLC on June 15, 2020. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: MasterPharm LLC
- Inspection Date: 2020-06-15
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations I
- Summary: This FDA Form 483, issued to MasterPharm LLC, a producer of sterile and non-sterile drug products located at 115-02 Liberty Avenue, South Richmond Hill, NY, details observations from an inspection conducted on May 28-29, June 1, 8, and 15, 2020. The inspection identified several significant violations.

Observation 1 notes that the firm released approximately (b)(4) Tadalafil 7 mg Capsules, Lot #01-22-2020, with a confirmed out-of-specification (OOS) potency of 80.4% (specification 1(b)(4)%), which were dispensed and remained on the market.

Observation 2 highlights difficult-to-clean, particle-generating, and visibly dirty equipment and surfaces in ISO-classified aseptic processing areas. Specifically, dark marks were observed on the material (b)(4) separating ISO 5 and ISO 7 areas, used for transferring materials for sterile products, without a cleaning regimen. Hard-to-reach (b)(4) areas within the ISO 5 Cleanroom (b)(4) were also not cleaned.

Observation 3 details non-microbial contamination, including rust-like material on a sanitizer dispenser in the ISO 7 anteroom and visible white product residue and chipped metallic coating on a flammable container in the ISO 7 hazardous non-sterile

## Related Documents

- [483 - 2015-05-06](https://www.keypedia.com/records/483/masterpharm-llc/79454088-dfe6-4c5e-bf8b-de15484e9df4)
- [483 - 2017-01-30](https://www.keypedia.com/records/483/masterpharm-llc/c0680046-cbeb-4ef9-90e6-98d5db128ac2)
- [STATE_REFERRAL_LETTER - 2017-01-17](https://www.keypedia.com/records/state_referral_letter/masterpharm-llc/9609a69c-1cc3-4779-9302-f19b15955812)
- [483 - 2020-06-15](https://www.keypedia.com/records/483/masterpharm-llc/d0bc1619-08bc-4362-b6f0-873017cf0e54)

## Related Officers

- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.keypedia.com/companies/masterpharm-llc/b5a31eae-f18d-4f02-a43e-f9e1a2046982

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-i/6ded4818-ee3a-46a1-84c1-36de58502b02