PediFix, Inc.
Form 483 issued February 12, 2024 · Brewster, New York
- Inspection
- Feb 8 – Feb 12, 2024
- Investigator
- Syeda N. Mahazabin
- Observations
- 2
- Pages
- 3
- FEI number
- 3009710062
In short: On February 12, 2024, FDA issued a Form 483 with 2 observations to PediFix, Inc. in Brewster, New York (FEI 3009710062) after an inspection that ran Feb 8 – Feb 12, 2024. The investigator was Syeda N. Mahazabin. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.22(a) (1×) · 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks responsibility for approving or rejecting drug products manufactured, processed, packed and…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Syeda N. Mahazabin
19 documents · 2006–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmPediFix, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PediFix, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected PediFix, Inc.?
Syeda N. Mahazabin is named on this Form 483, for the inspection of Feb 8 – Feb 12, 2024. Each investigator has a profile showing what they cite most.
When was PediFix, Inc. inspected by FDA?
The inspection ran Feb 8 – Feb 12, 2024, and the Form 483 is dated February 12, 2024.
How do I get the full Form 483 for PediFix, 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.