Teva API India Ltd- Malanpur
Form 483 issued April 16, 2019 · Malanpur, India
- Inspection
- Apr 8, 2015 – Apr 16, 2019
- Observations
- 4
- Pages
- 5
- FEI number
- 3008256596
In short: On April 16, 2019, FDA issued a Form 483 with 4 observations to Teva API India Ltd- Malanpur in Malanpur, M.P (FEI 3008256596) after an inspection that ran Apr 8, 2015 – Apr 16, 2019. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Quality system and facilities & equipment account for 4 of 4 observations.
Most cited: 21 CFR 211.22 (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
Risk Assessments performed by your firm’s Quality Unit are inadequate in that they do not evaluate…
- 02
Your firm’s cleaning processes for non-dedicated equipment have not been…
- 03
The responsibilities and procedures applicable to the Quality Unit…
- 04
Production equipment is 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 Teva API India Ltd- Malanpur?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Teva API India Ltd- Malanpur inspected by FDA?
The inspection ran Apr 8, 2015 – Apr 16, 2019, and the Form 483 is dated April 16, 2019.
How do I get the full Form 483 for Teva API India Ltd- Malanpur?
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.