§213.122. Materials examination and usage criteria. — Inbound Citations
21 C.F.R. § 213.122
Statutory Authority
Cited by 3 regulations in release Current.
Citations to 21 C.F.R. § 213.122 as a whole
-
(iii) Section 213.122 of this chapter. Materials examination and usage criteria.
-
Citations to §213.122(f)(2)
-
(b) Procedures shall be used to reconcile the quantities of labeling issued, used, and returned, and shall require evaluation of discrepancies found between the quantity of medical gas and the quantity of labeling issued when such discrepancies are outside narrow preset limits based on historical operating data. Such discrepancies shall be investigated in accordance with § 213.192. Labeling reconciliation is waived for cut or roll labeling if a 100-percent examination for correct labeling is performed in accordance with § 213.122(f)(2). Labeling reconciliation is also waived for 360° wraparound labels on portable cryogenic medical gas containers.