MENTHA AND ALLIED PRODUCTS PRIVATE LIMITED
Form 483 issued September 25, 2024 · Rampur, India
- Observations
- 16
- Pages
- 21
- FEI number
- 3004293613
In short: On September 25, 2024, FDA issued a Form 483 with 16 observations to MENTHA AND ALLIED PRODUCTS PRIVATE LIMITED in Rampur, Uttar Pradesh (FEI 3004293613). Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.160 (3×) · 211.68 (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 control unit are not in…
- 02
Failure to thoroughly investigate and document product complaints according to a written…
- 03
Failure to train all personnel in current good manufacturing practices (CGMP) and in the…
- 04
Repeat Observation Test procedures for product release and stability were not appropriate, properly executed, verified, or…
This inspection in context
Questions about this 483
What did FDA find at MENTHA AND ALLIED PRODUCTS PRIVATE LIMITED?
FDA listed 16 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was MENTHA AND ALLIED PRODUCTS PRIVATE LIMITED inspected by FDA?
This Form 483 is dated September 25, 2024.
How do I get the full Form 483 for MENTHA AND ALLIED PRODUCTS PRIVATE LIMITED?
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