USFDA Untitled Letter To Nectar Cites Deficiencies in Sterile Processes, Facility Monitoring

Nectar Lifesciences was issued an Untitled letter (UL) by USFDA in Sep 23 citing deficiencies in sterile processes, sterile facility and facility monitoring. The untitled letter follows deficiencies observed during an FDA inspection at Nectar Baddi (india) facility during March 2023.

Deficiencies cited in the UL are:

1. Inadequate procedures & controls for sterile operations to prevent microbial contamination of sterile drug products
   1. Media fill studies fail to simulate various critical interventions during actual operations; batch size of media fill studies is only a small portion of actual production batch size.
   1. Smoke studies do not determine dynamic conditions of aseptic line; inadequate unidirectional flow and visualisation of airflow do not substantially assess whether airflow is protecting drug products from contamination.
   1. Poor aseptic techniques by operators during manual interventions – reaching out over open vials to remove empty / fallen vials, leaving aseptic lines open for extended period.
2. Inadequate monitoring of environmental conditions in aseptic areas:
   1. Inadequate building management systems (BMS), manual monitoring of clean rooms for differential pressures (DP), Temperature (T) and Humidity (RH) on infrequent basis. Intermittent monitoring and recording of DP is not acceptable in aseptic processing areas

Firm is asked to provide independent assessment of all contamination hazards with respect to aseptic processes, program for monitoring DP, Temperature and Humidity, retrospective impact assessment and remediation plans.

Untitled Letters and Warning Letters are Advisory actions taken by FDA to achieve voluntary compliance when there are violations of cGMPs and the Federal Food, Drug and Cosmetic Act. Warning Letters are issued only for violations of regulatory significance and may lead to other enforcement action, such as an injunction, recall, seizure, administrative detention, civil money penalties and/or prosecution to achieve correction, if not promptly and adequately corrected. Untitled letters are used for violations that may not meet the threshold of regulatory significance for a warning letter and request correction of the violations. Untitled letter does not include a statement of warning of enforcement action; however FDA is under no legal obligation to warn firms before taking enforcement action.

Also Refer USFDA Regulatory Procedures Manual Chapter 4: ADVISORY ACTIONS

Nectar Untitled Letter