Chemeca Drugs Private Limited
Form 483 issued March 10, 2021 · Anakapalli, India
- Inspection
- Mar 2 – Mar 10, 2021
- Observations
- 4
- Pages
- 5
- FEI number
- 3010630993
In short: On March 10, 2021, FDA issued a Form 483 with 4 observations to Chemeca Drugs Private Limited in Anakapalli, Andhra Pradesh (FEI 3010630993) after an inspection that ran Mar 2 – Mar 10, 2021. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 4 of 4 observations.
Most cited: 21 CFR 211.192 (2×) · 211.67 (2×)
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 applicable to the Quality Unit are not in…
- 02
Effective date 7/1/2018 “Cleaning and Storage of ags after sages. Investigations are inadequate in that the…
- 03
Your firm’s cleaning processes for non-dedicated equipment have not been…
- 04
Production equipment are not stored appropriately to prevent contamination or carry-over of a material that would…
This inspection in context
Questions about this 483
What did FDA find at Chemeca Drugs Private Limited?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Chemeca Drugs Private Limited inspected by FDA?
The inspection ran Mar 2 – Mar 10, 2021, and the Form 483 is dated March 10, 2021.
How do I get the full Form 483 for Chemeca Drugs 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.