Pharbest Pharmaceuticals, Inc.
Form 483 issued November 10, 2022 · Farmingdale, New York
- Inspection
- Nov 7 – Nov 10, 2022
- Investigators
- Amatul H. Marium· Syeda N. Mahazabin· Tanya R. Syffrard
- Observations
- 7
- Pages
- 6
- FEI number
- 3005382247
In short: On November 10, 2022, FDA issued a Form 483 with 7 observations to Pharbest Pharmaceuticals, Inc. in Farmingdale, New York (FEI 3005382247) after an inspection that ran Nov 7 – Nov 10, 2022. The investigators were Amatul H. Marium, Syeda N. Mahazabin and Tanya R. Syffrard. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
An adequate number of batches of each drug product are not tested to determine…
- 03
Written records of investigations into unexplained discrepancies do not always include…
- 04
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
This inspection in context
Amatul H. Marium
8 documents · 2022–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New York.
The firmPharbest Pharmaceuticals, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharbest Pharmaceuticals, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Pharbest Pharmaceuticals, Inc.?
Amatul H. Marium, Syeda N. Mahazabin and Tanya R. Syffrard are named on this Form 483, for the inspection of Nov 7 – Nov 10, 2022. Each investigator has a profile showing what they cite most.
When was Pharbest Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Nov 7 – Nov 10, 2022, and the Form 483 is dated November 10, 2022.
How do I get the full Form 483 for Pharbest Pharmaceuticals, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.