MSN Pharmachem Private Limited
Form 483 issued April 21, 2023 · Patancheru (Mandal), India
- Inspection
- Apr 17 – Apr 21, 2023
- Investigator
- Rachael O. Oyewole
- Observations
- 1
- Pages
- 2
- FEI number
- 3006165229
In short: On April 21, 2023, FDA issued a Form 483 with 1 observation to MSN Pharmachem Private Limited in Patancheru (Mandal), Telangana (FEI 3006165229) after an inspection that ran Apr 17 – Apr 21, 2023. The investigator was Rachael O. Oyewole. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×) · 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures of the quality unit are not in…
This inspection in context
Rachael O. Oyewole
10 documents · 2020–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmMSN Pharmachem Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MSN Pharmachem Private Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. 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 MSN Pharmachem Private Limited?
Rachael O. Oyewole is named on this Form 483, for the inspection of Apr 17 – Apr 21, 2023. Each investigator has a profile showing what they cite most.
When was MSN Pharmachem Private Limited inspected by FDA?
The inspection ran Apr 17 – Apr 21, 2023, and the Form 483 is dated April 21, 2023.
How do I get the full Form 483 for MSN Pharmachem Private Limited?
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.